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Completed

NCT Number: NCT00438633

Comparison of Early and Late Therapy for Adults With Non-Operatively Treated Proximal Humerus Fractures

The purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

Proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. There is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. However, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. Some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. Others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and Female patients.
  • Any race
  • Older than 18y
  • Diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: X rays and/or CT Scans.
  • Any type of proximal humeral fracture according to the Neer or AO classification system.
  • Patient should have received non-operative treatment.

Exclusion criteria

  • Patients younger than 18 y.
  • Patients with multiple other fractures.
  • Patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.

Treatment and study plan

Primary outcomes

  1. Shoulder Flexion

    Time frame: 6 months

    We measured active forward flexion of the shoulder

Secondary outcomes

  1. Shoulder Pain Likert Scores

    Time frame: 3 months, 6 months

    Rated on a scale of 0-10, where 0 is no pain and 10 is severe pain.

  2. External Rotation

    Time frame: 3 months, 6 months

  3. Abduction

    Time frame: 3 months, 6 months

  4. Disability of the Hand, Shoulder, and Arm Score

    Time frame: 3 months, 6 months

    Disability of the Hand, Shoulder, and Arm Score (DASH) is a measure of upper extremity physical function, with scores ranging from 0 to 100. A higher score indicates more physical impairment.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Early vs Delayed Physical Therapy (Exercises) for Non-Operatively-Treated Proximal Humerus Fractures: A Prospective Randomized Trial

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Feb 22, 2007
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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